This webinar will summarize the Sunshine Act or Open Payments Program requirements and provide practical solutions to the most common situations that are prevalent and necessary between sponsors and investigators.
The Sunshine Act or Open Payments Program requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain clinical investigator payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and the industry.
WHY SHOULD YOU ATTEND?
The Sunshine Act exposes the physicians and sponsors to new clinical trial reporting requirements and detail non-compliance which would lead to hefty fines. Templates for reporting format, exemptions to reporting requirements, and timelines for compliance and enforcement will be discussed.
AREA COVERED
Life science companies face the challenge of implementing the detailed reporting required by the Act as healthcare providers determine how to use their own data to anticipate public reporting of payments by life science companies to physicians and teaching hospitals.
This webinar will examine the implications of the Sunshine Act for healthcare providers and life science companies and discuss practical steps they can take to implement the Act and prepare for transparency.
- Purpose of the Sunshine Act
- Who is required to report under the Sunshine Act?
- What is reported?
- Exclusions
- Tracking
- Penalties
- Useful links
WHO WILL BENEFIT?
- Manufacturers of FDA-regulated products: Drug, Medical Device, and Biotech Companies
- Clinical Trial Professionals such as Project Managers, CRAs, Medical Writers
- Senior Management for Companies developing new products for the US market
- Regulatory Affairs Professionals
- People investing in FDA-regulated products intended for the US market
The Sunshine Act exposes the physicians and sponsors to new clinical trial reporting requirements and detail non-compliance which would lead to hefty fines. Templates for reporting format, exemptions to reporting requirements, and timelines for compliance and enforcement will be discussed.
Life science companies face the challenge of implementing the detailed reporting required by the Act as healthcare providers determine how to use their own data to anticipate public reporting of payments by life science companies to physicians and teaching hospitals.
This webinar will examine the implications of the Sunshine Act for healthcare providers and life science companies and discuss practical steps they can take to implement the Act and prepare for transparency.
- Purpose of the Sunshine Act
- Who is required to report under the Sunshine Act?
- What is reported?
- Exclusions
- Tracking
- Penalties
- Useful links
- Manufacturers of FDA-regulated products: Drug, Medical Device, and Biotech Companies
- Clinical Trial Professionals such as Project Managers, CRAs, Medical Writers
- Senior Management for Companies developing new products for the US market
- Regulatory Affairs Professionals
- People investing in FDA-regulated products intended for the US market
Speaker Profile

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she …
Upcoming Webinars

Interactive dashboards & analytics in Excel

Copilot and HR: An Introduction for HR Professionals

4-Hour Virtual Seminar on Bootcamp on Excel

Leading Across Generations: 5 Challenges & 10 Strategies to…


I-9 Audits: Strengthening Your Immigration Compliance Strat…

Fair Lending in 2025: New Regulations, Examinations and Enf…


Tattoos, hijabs, piercings, and pink hair: The challenges …

Using Emotional Intelligence to Elevate Your Leadership

ChatGPT & HR: How HR Recruiting Professionals Can Leverage …

FDA Trends in Compliance and Enforcement in Computer System…

Elevate Your Workplace Wellness: 10 Critical Wellness Facto…

How to Manage the Legal Landmine of the FMLA, ADA and Worke…

How to Write a Successful Job Hazard Analysis


How to Write Right for Better Business Communication

How to Prepare For and Host a FDA Inspection and Respond to…

Public Speaking: Overcoming The Fear of Public Speaking

From Good to Great: The Secrets to an Optimized LinkedIn Pr…



Workplace Investigations 101: How to Conduct your Investiga…

Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…

The Five Cs Of Commercial Credit: The Basic Elements Of Cre…

Transforming Anger And Conflict Into Collaborative Problem …


Navigating Alcohol and Drug Addiction Protections Under the…


Reduce Stress in the Workplace: Effective Ways to Handle Co…



Transforming HR with AI: Unlocking Excellence and Innovation

Creating Employee Handbooks that Protect You and Support th…

FDA Technology Modernization Action Plan (TMAP) and Impact …


Transform Data into Insights: A Beginners Guide to Excel Pi…


Mindful Communication:The Key to Meaningful Conversations i…

FDA Proposes Framework to Advance Credibility of AI Models

50+ new Excel features so far this decade

FMLA Compliance in 2025: A Comprehensive Guide & Strategies…

Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…

Managing Toxic Employees: Strategies For Leaders To Effecti…

Hiring and Retaining Employees in this Crazy Economy

Harassment, Bullying, Gossip, Confrontational and Disruptiv…